A Study to Assess the Cardiac Safety of Oritavancin in Healthy Volunteers

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This study will be a single-center, double-blind, randomized, placebo-controlled parallel design study with an open label positive-control moxifloxacin arm to evaluate the effect of supratherapeutic dose of oritavancin on the QT and QTc intervals.

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Ages Eligible for Study:

18 Years to 60 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Able to give written informed consent before initiation of any study related procedures and willing to comply with all required study procedures.

Healthy, male and female between 18 and 60 years old, BMI between 18 kg/m2 and 30 kg/m2

In good health based upon results of medical history, physical examination, no clinically significant 12-lead ECG results, and laboratory test results.

Serum magnesium and potassium levels within the normal range at screening.

Agree to abstain from alcohol, caffeine-, and xanthine-containing products, all kind of energy drinks and the consumption of grapefruit juice and orange juice from 48 hours before study drug administration until completion of the follow-up visit.

Exclusion Criteria:

History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, televancin, daptomycin, or teicoplanin) or any of their excipients. Note: patients who have had histamine-like infusion reactions to a glycopeptide are not excluded

Respiratory difficulties, or a history of asthma or chronic obstructive pulmonary disease

Use of any prescription drug or over-the-counter (OTC) medications or herbal preparations within 14 days or 5-times the elimination half-life (whichever is longer) prior to starting the study (except for acetaminophen; birth control pills; implantable or injectable birth control; and estrogen, testosterone, and/or progesterone replacement in menopausal women)

Unwilling to abstain from smoking for the duration of the study.

Any clinically-significant, underlying abnormalities in rhythm, conduction, or morphology of the resting ECG that may interfere with the interpretation of QTc interval changes

Positive result for the urine or serum human chorionic gonadotropin (hCG) test administered at screening (females with child bearing potential)

A past medical history of clinically significant ECG abnormalities or a family history (grandparents, parents, or siblings) of either a long or a short QT syndrome

Personal history of unexplained syncope.

Women who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 acceptable methods of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier method(s) or male partner sterilization). Women ≥2 years postmenopausal or surgically sterile are exempt from this exclusion

A history of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents